- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02653352
Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas
8. januar 2016 opdateret af: Rosely Sichieri, Rio de Janeiro State University
School Randomised Trial on Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas
The purpose of this study was to encourage students to reduce soft drinks intake, substituting it by water, in order to prevent and control overweight prevalence.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
During seven months of one school year, a healthy lifestyle education programme was implemented using simple messages encouraging water consumption instead of sugar sweetened carbonated beverages.
The messages were previously tested for understanding in two small groups of children of the same age and socio-economic background as the study participants.
Also, beliefs and behaviors of children in these focus groups were recorded in order to orient activities and the production of printed materials to be given to participants.
Education was delivered via classroom activities; banners were hung promoting water consumption, and water bottles with the logo of the campaign were given to children and schoolteachers.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1140
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
9 år til 12 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 4th grade morning classes
Exclusion Criteria:
- Pregnancy
- Physical disabilities preventing anthropometric measurement
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control
The control group received two one-hour general sessions on health issues and printed general advices regarding healthy diets.
|
|
|
Eksperimentel: Lifestyle modification
Intervention was focused on the reduction in consumption of sugar-sweetened carbonated beverages by students.
During seven months of one school year, a healthy lifestyle education programme was implemented using simple messages encouraging water consumption instead of sugar-sweetened carbonated beverages.
Education was delivered via classroom activities; banners were hung promoting water consumption, and water bottles with the logo of the campaign were given to children and schoolteachers.
|
The centre of the campaign was to encourage the exchange of sugar-sweetened beverages for water.
Ten one-hour sessions of activities facilitated by four trained research assistants were assigned for each class.
The activities required 20-30 min and teachers were encouraged to reiterate the message during their lesson.
Classroom quizzes and games using water v. sugar-sweetened carbonated beverages as the theme, as well as song and drawing competitions, were promoted.
In addition, a musician using a tambourine helped each class to collectively develop songs related to drinking water and reducing the consumption of sugar-sweetened carbonated beverages.
This musical activity was conducted during three one-hour sessions.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in body mass index (kg/m²)
Tidsramme: baseline, 8 months
|
We have calculated changes in body mass index (BMI in follow-up minus BMI on baseline) and compared mean changes between control and intervention groups, in order to address differences in BMI gain among groups.
|
baseline, 8 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in overweight prevalence as assessed by percentage of overweight participants
Tidsramme: baseline, 8 months
|
Prevalence of overweight was assessed in both groups (intervention and control) in baseline and at the end of follow-up, according to standard definition proposed by Cole et al., 2000.
Then, we evaluated changes in prevalences among groups.
|
baseline, 8 months
|
|
Change in obesity prevalence as assessed by percentage of obese participants
Tidsramme: baseline, 8 months
|
Prevalence of obesity was assessed in both groups (intervention and control) in baseline and at the end of follow-up, according to standard definition proposed by Cole et al., 2000.
Then, we evaluated changes in prevalences among groups.
|
baseline, 8 months
|
|
Change in blood cholesterol
Tidsramme: baseline, 8 months
|
baseline, 8 months
|
|
|
Change in blood glucose
Tidsramme: baseline, 8 months
|
baseline, 8 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Rosely Sichieri, PhD, State University of Rio de Janeiro
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Malik VS, Pan A, Willett WC, Hu FB. Sugar-sweetened beverages and weight gain in children and adults: a systematic review and meta-analysis. Am J Clin Nutr. 2013 Oct;98(4):1084-102. doi: 10.3945/ajcn.113.058362. Epub 2013 Aug 21.
- Schulze MB, Manson JE, Ludwig DS, Colditz GA, Stampfer MJ, Willett WC, Hu FB. Sugar-sweetened beverages, weight gain, and incidence of type 2 diabetes in young and middle-aged women. JAMA. 2004 Aug 25;292(8):927-34. doi: 10.1001/jama.292.8.927.
- Sichieri R, Paula Trotte A, de Souza RA, Veiga GV. School randomised trial on prevention of excessive weight gain by discouraging students from drinking sodas. Public Health Nutr. 2009 Feb;12(2):197-202. doi: 10.1017/S1368980008002644. Epub 2008 Jun 18.
- Vargas IC, Sichieri R, Sandre-Pereira G, da Veiga GV. Evaluation of an obesity prevention program in adolescents of public schools. Rev Saude Publica. 2011 Feb;45(1):59-68. doi: 10.1590/s0034-89102011000100007. English, Portuguese.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2005
Primær færdiggørelse (Faktiske)
1. december 2005
Studieafslutning (Faktiske)
1. december 2005
Datoer for studieregistrering
Først indsendt
23. november 2015
Først indsendt, der opfyldte QC-kriterier
8. januar 2016
Først opslået (Skøn)
12. januar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. januar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. januar 2016
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 500404/2003-8
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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